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Manejo conservador de la impactación del bolo alimenticio blando esofágico

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Antecedentes

La impactación de un bolo alimenticio blando en el esófago causa disfagia y regurgitación. Si el bolo no se desplaza de forma espontánea, el paciente corre el riesgo de aspiración, deshidratación, perforación y muerte. El tratamiento definitivo incluye una intervención endoscópica, recomendada dentro de las 24 horas. Antes de la endoscopia, muchos pacientes son sometidos a un período de observación, a la espera de una desimpactación espontánea, o pueden ser sometidos a tratamientos enterales o parenterales para tratar de desplazar el bolo. Hay poco consenso en cuanto a cuál de estas estrategias conservadoras es segura y efectiva para ser utilizada en este período inicial, antes de recurrir al tratamiento endoscópico definitivo para la impactación persistente.

Objetivos

Evaluar la eficacia de los tratamientos conservadores no endoscópicos en el tratamiento de los bolos de alimentos blandos impactados dentro del esófago.

Métodos de búsqueda

Se realizaron búsquedas en las siguientes bases de datos, utilizando los términos de búsqueda pertinentes: Registro Cochrane Central de Ensayos Controlados (Cochrane Central Register of Controlled Trials, CENTRAL), MEDLINE, Embase y CINAHL. La fecha de la búsqueda fue el 18 de agosto 2019. Se examinaron las listas de referencia de los estudios y revisiones pertinentes sobre el tema para identificar cualquier estudio adicional.

Criterios de selección

Se incluyeron ensayos controlados aleatorizados del tratamiento de la impactación aguda del bolo alimenticio blando esofágico, en adultos y niños, que informaron sobre la incidencia de la desimpactación (confirmada radiológica o clínicamente mediante el retorno a la dieta oral) sin necesidad de intervención endoscópica. No se incluyeron estudios centrados en la impactación de objetos afilados o sólidos.

Obtención y análisis de los datos

Se utilizaron los procedimientos metodológicos estándar recomendados por la Colaboración Cochrane.

Resultados principales

Se identificaron 890 registros únicos a través de las búsquedas electrónicas. Se excluyeron 809 registros claramente irrelevantes y se recuperaron 81 registros para su evaluación adicional. Posteriormente se incluyó un ensayo controlado aleatorizado que cumplía los criterios de elegibilidad, que se realizó en cuatro centros suecos y asignó al azar a 43 participantes para recibir diazepam intravenoso seguido de glucagón o placebos intravenosos. El efecto de las sustancias activas comparadas con el placebo en las tasas de desimpactación sin intervención es incierto, ya que los números de este único estudio fueron pequeños y las tasas fueron similares (38% versus 32%; riesgo relativo 1,19; intervalo de confianza del 95%: 0,51 a 2,75; P = 0,69). La certeza de la evidencia según los criterios GRADE para este resultado es baja. Hubo una falta de datos sobre los eventos adversos.

Conclusiones de los autores

En la actualidad no hay datos adecuados para recomendar el uso de un tratamiento enteral o parenteral para la impactación aguda del bolo alimenticio blando esofágico. Tampoco se dispone de datos adecuados sobre los efectos adversos potenciales de la utilización de dichos tratamientos, ni sobre las posibles demoras en el tratamiento endoscópico definitivo. Se debe tener cuidado al utilizar cualquier estrategia de manejo conservador en estos pacientes.

PICO

Population
Intervention
Comparison
Outcome

El uso y la enseñanza del modelo PICO están muy extendidos en el ámbito de la atención sanitaria basada en la evidencia para formular preguntas y estrategias de búsqueda y para caracterizar estudios o metanálisis clínicos. PICO son las siglas en inglés de cuatro posibles componentes de una pregunta de investigación: paciente, población o problema; intervención; comparación; desenlace (outcome).

Para saber más sobre el uso del modelo PICO, puede consultar el Manual Cochrane.

Resumen en términos sencillos

Uso de tratamientos para desplazar alimentos blandos atascados entre la garganta y el estómago con el objeto de tratar de evitar la necesidad de endoscopia

Pregunta de la revisión

¿Un período de observación, el tratamiento con sustancias ingeridas o el tratamiento con sustancias administradas por vía sanguínea pueden ayudar a desplazar los alimentos blandos que están atascados entre la garganta y el estómago para evitar la necesidad de un procedimiento endoscópico para eliminarlos?

Antecedentes

La comida a veces puede atascarse en el esófago, el tubo que conecta la garganta con el estómago y que atraviesa el pecho. Este alimento a menudo se desplaza por sí solo, sin ninguna ayuda médica, pero ocasionalmente se necesita la ayuda de un médico para eliminarlo. La extracción o el desplazamiento de estas masas de comida se pueden realizar con una cámara flexible o un instrumento rígido, llamado endoscopio, pero los procedimientos endoscópicos pueden tener complicaciones graves, como la posibilidad de causar orificios en el esófago. Sin embargo, esperar demasiado tiempo para que el alimento se elimine por sí solo también puede aumentar el riesgo de que se produzca un orificio en el esófago y puede dar lugar a que la saliva o el alimento se desplace a los pulmones, lo cual puede causar infecciones graves. En la actualidad se utilizan diversos tratamientos para tratar de eliminar los alimentos sin tener que recurrir a una endoscopia, muchos de los cuales también tienen efectos secundarios potenciales, como dificultad para respirar, aumento de los niveles de azúcar en la sangre, presión arterial baja y latidos cardíacos irregulares. Se deseaba saber si alguno de estos tratamientos era mejor que esperar a que la comida se eliminara por sí sola, antes de intentar desplazarla con instrumentos.

Características de los estudios

La evidencia está actualizada hasta agosto 2019. Se encontró un ensayo adecuado para responder a la pregunta, que comparaba la administración de dos fármacos intravenosos a un paciente (diazepam y glucagón) con placebos (líquidos claros que parecían similares a los fármacos pero que no tenían ningún efecto en el cuerpo). No se consideró el tratamiento de objetos afilados o duros, ya que los mismos se tratan de manera diferente.

Resultados clave

No hubo evidencia suficiente para establecer con certeza qué tratamientos para los alimentos impactados en el esófago son seguros o efectivos.

Calidad de la evidencia

La certeza general de la evidencia se calificó como baja. Se necesitan más estudios con más participantes para poder responder a la pregunta de la revisión.

Authors' conclusions

Implications for practice

There is currently inadequate data to recommend the use of any conservative treatments in the management of oesophageal soft food bolus impaction. The overall certainty of the evidence is low, with only a single, small randomised trial contributing to this assessment.

There are potentially serious side effects and complications from the treatments currently used to manage soft food bolus impaction, as well as potentially serious consequences from delaying disimpaction with a watchful waiting strategy. This review has identified insufficient evidence to adequately comment on the adverse effects of any proposed management strategy. Caution should be exercised when using any of the treatments considered in this review, including intentional delay of definitive endoscopic management.

Implications for research

Significantly more experimental studies are needed before this review question can be adequately addressed. All current management strategies risk exposure of patients to potential harm, whether that be from the treatments themselves, or from any delay in impacted bolus being cleared. The single randomised controlled trial identified by this review has too few participants to adequately comment on the effectiveness of the interventions (diazepam and glucagon) or the effectiveness of watchful waiting or placebo. Future studies should consider randomising participants at the time of presentation to either a definitive endoscopic procedure, or a conservative management strategy including observation, enteral and parenteral treatments. This will allow adequate assessment of both the efficacy of the treatments and of any adverse events resulting from delay in treatment or definitive endoscopic management itself.

Summary of findings

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Summary of findings 1. Diazepam and glucagon compared to placebo for the management of impacted food bolus in the oesophagus

Diazepam and glucagon compared to placebo for the management of impacted food bolus in the oesophagus

Patient or population: management of impacted food bolus in the oesophagus
Setting: 4 Swedish ear, nose, and throat (ENT) departments
Intervention: diazepam and glucagon
Comparison: placebo

Outcomes

Anticipated absolute effects* (95% CI)

Relative effect
(95% CI)

№ of participants
(studies)

Certainty of the evidence
(GRADE)

Comments

Risk with placebo

Risk with diazepam and glucagon

Disimpaction

Study population

RR 1.19
(0.51 to 2.75)

43
(1 RCT)

⊕⊕⊝⊝
LOW 1

No significant effect from combined diazepam and glucagon compared to placebo

32 per 100

38 per 100
(16 to 87)

*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).

CI: confidence interval; RCT: randomised controlled trial; RR: risk ratio

GRADE Working Group grades of evidence
High certainty: We are very confident that the true effect lies close to that of the estimate of the effect.
Moderate certainty: We are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different.
Low certainty: Our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect.
Very low certainty: We have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect.

1We assessed imprecision as very serious as the single identified study had a wide 95% confidence interval spanning 1.0.

Background

See glossary of terms in Appendix 1.

Description of the condition

The oesophagus is a muscular tube that acts as a conduit between the throat and stomach. It begins at the end of the pharynx, travels through the neck and thorax, and finishes in the abdomen at the stomach. The oesophagus is between 18 cm and 25 cm in length and comprises skeletal muscle proximally, smooth muscle distally, and a mixture in its central portion (Gatzoulis 2009). Boluses of swallowed food are moved along this muscular tube by co‐ordinated waves of contractility, called peristalsis. Food or other material can become ‘impacted’ in the oesophagus, resulting in partial or total oesophageal obstruction. Many of these impactions resolve spontaneously and therefore never present to healthcare professionals (Liu 2012). The remainder may present acutely to hospital emergency departments, with subsequent referral on to ear, nose, and throat (ENT) surgeons or gastroenterologists for further management.

Non‐organic oesophageal foreign bodies, or organic food boluses that have hard or sharp components (e.g. bone), pose a significant risk of perforating the oesophageal wall (Barabino 2015; Mezzetto 2016; Park 2016). As such, they are managed differently as they require immediate removal via rigid or flexible oesophagoscopy. Soft food boluses impacted in the oesophagus are not considered to pose this same immediate risk and so may be subjected to ‘conservative’ strategies to encourage disimpaction, aiming to avoid definitive endoscopic management. These soft food bolus impactions were the focus of this review.

Any delay in disimpaction may expose the patient to potential harm. Being unable to swallow causes distress and discomfort and can rapidly lead to dehydration, as secretions are not resorbed and normal enteral nutrition is prevented. Additionally, the patient is at risk of aspirating these substances into the tracheobronchial system, placing them at risk of pneumonia (Loh 2000). Finally, the bolus itself may also cause local trauma to the adjacent oesophageal mucosa. This local pressure effect may cause inflammation, progressing to ischaemia, perforation, and mediastinitis (Liu 2012). This carries a mortality approaching 100% if not treated promptly (Bladergroen 1986). As such, timely disimpaction of these soft food boluses may be needed to prevent serious sequelae.

Description of the intervention

An endoscopic procedure known as oesophagoscopy is considered definitive management for persistent cases of impaction. The lumen of the oesophagus is visualised, and the bolus is either advanced into the stomach or retrieved through the mouth. This may be performed with either a flexible or rigid endoscope, both of which are associated with potentially serious complications (Ferrari 2018; Wennervaldt 2012). The American Society for Gastrointestinal Endoscopy recommends definitive management of the oesophageal food bolus within 24 hours wherever possible, to prevent complications from delayed disimpaction (Ikenberry 2011; Loh 2000; Park 2004). Consequently, a number of ‘conservative’ treatments and strategies are employed in an attempt to avoid the need for endoscopic intervention within this early period. This may involve a simple period of observation, otherwise known as ‘watchful waiting’. Further to this, there are a number of more active treatments that are commonly used. These may be delivered parenterally, having their effects on the tissues of the oesophagus via the blood, or enterally, having a direct effect within the lumen of the oesophagus.

How the intervention might work

Watchful waiting

Observation, or watchful waiting, aims to allow more time for the bolus to pass spontaneously. The muscle fibres surrounding the bolus may be in spasm, and so a period of observation will allow time for them to relax spontaneously and the bolus to pass into the stomach through normal processes. Watchful waiting aims to avoid the need for any form of intervention, whether endoscopic, enteral, or parenteral, thereby avoiding any associated side effects or complications. However, there may be increased risks from this delaying strategy, including immediate or late perforation if the bolus remains impacted for too long (Loh 2000; Park 2004).

Parenteral treatments

Parenteral treatments may be administered subcutaneously, intramuscularly, or intravenously. They are proposed to relax the musculature of the oesophageal wall, thereby allowing the impacted bolus to pass into the stomach. Depending on the level of impaction within the oesophagus, these medications may target smooth muscle or skeletal muscle. Commonly used medications are highlighted below.

Benzodiazepines increase the effects of gamma amino butyric acid (GABA) at the GABA‐A receptor, reducing the excitability of neurons. Amongst other effects, this can relax the skeletal muscle in the proximal oesophagus. Benzodiazepines must be used cautiously due to their potentially serious side effect of central respiratory depression (Griffin 2013).

Hyoscine butylbromide is an anticholinergic agent, which inhibits parasympathetic actions on smooth muscle, resulting in relaxation and dilatation. It may be given subcutaneously, intramuscularly, or intravenously and is most commonly administered four times daily (Tytgat 2007). There are no serious side effects commonly encountered with hyoscine butylbromide.

Glucagon is a single‐chain polypeptide hormone that works to raise serum glucose level and also relax smooth muscle in the lower oesophageal sphincter and distal oesophagus. It may be given subcutaneously, intramuscularly, or intravenously (Colon 1999). Side effects include hyperglycaemia, and caution should be exercised with use in diabetic patients.

Calcium channel blockers inhibit the entry of calcium ions into smooth muscle cells, reducing their ability to contract and so allowing dilatation (Katz 1986). They are used primarily in cardiovascular disease, and so common potentially serious side effects include arrhythmias and hypotension. Calcium channel blockers must be used with caution alongside other cardiovascular drugs.

Enteral treatments

Enteral treatments work within the oesophageal lumen, directly on the bolus itself. The patient may take them orally or they may be administered through the nose with the help of a suitable conduit.

Gas‐forming or effervescent agents, such as carbonated drinks, may be drunk by the patient. The proposed mechanism of action is to create increased pressure between the obstruction and cricopharyngeal sphincter above, propelling the food bolus inferiorly towards the stomach (David 2019).

Pineapple juice contains bromelain, which is a proteolytic enzyme that aims to soften and dissolve the food bolus (Thomas 2004). Papain is derived from papaya fruit and has a similar proteolytic mechanism of action. The practice of enzymatic disimpaction has largely ceased because of the non‐selective nature of the digestive agents, affecting not only the foreign body but also the oesophageal wall, which may increase the risk of subsequent perforation (Morse 2016). Once softened, the impacted bolus may loosen, and normal peristaltic actions may resume.

Non‐endoscopic instrumentation of the bolus may also be attempted, often through the nasal route to avoid stimulating a gag reflex in the patient. A nasogastric (NG) tube may be passed to interact with the bolus, without visualisation. The NG tube may also be used to deliver liquids, such as effervescent or proteolytic agents, or gas, such as room air, proximal surface of the bolus (Goldman 1994; Marano 2016). Blind instrumentation of an obstructed oesophagus may pose a perforation risk, particularly once it has been traumatised by an impacted food bolus.

Why it is important to do this review

Timely management of oesophageal food bolus impaction is essential to prevent life‐threatening complications, as outlined previously. Prevailing clinical consensus suggests that non‐endoscopic treatments and strategies should be used initially to help minimise the exposure to risk from endoscopic intervention. However, there is no robust evidence as to which methods should be employed, and for how long, before undergoing endoscopy. Endoscopic interventions have the potential to bring about faster resolution of the impaction, but the procedure carries potential risks and complications. Safe and effective treatments that help to avoid endoscopic intervention would therefore be justified.

Objectives

To evaluate the efficacy of non‐endoscopic conservative treatments in the management of soft food boluses impacted within the oesophagus.

Methods

Criteria for considering studies for this review

Types of studies

We considered randomised controlled trials that compared conservative (non‐endoscopic) treatments for impacted oesophageal food boluses against other conservative (non‐endoscopic) treatments, placebo, or watchful waiting.

Types of participants

Inclusion criteria

  • People of any age.

  • History of acute soft food bolus ingestion.

  • History suggestive of oesophageal impaction. This may manifest as complete aphagia, suggesting a proximal blockage, or with delayed regurgitation, which is more suggestive of a distal oesophageal impaction.

  • Reporting the incidence of disimpaction (confirmed radiologically or clinically by return to oral diet) without the need for endoscopic intervention, i.e. food bolus disimpaction without the need for oesophagoscopy.

Exclusion criteria

  • History of sharp‐ or solid‐object ingestion, whether food derived, such as animal bone, or ‘foreign’, such as dentures or coins.

Types of interventions

We considered the following:

  • all non‐endoscopic treatments, as outlined above. These are broadly divided into enteral treatments, parenteral treatments, and watchful waiting;

  • combinations of treatments, providing the allocated management did not include endoscopy;

  • all doses and dosing regimens;

  • all relevant parenteral routes: subcutaneous, intramuscular, and intravenous;

  • all comparisons of the above treatments, including comparisons with placebo.

Types of outcome measures

Primary outcomes

  • Incidence of disimpaction, without the need for endoscopic intervention, at any point prior to endoscopic intervention.

  • Serious adverse events (including aspiration, perforation, and death).

Secondary outcomes

  • Adverse events (including side effects and complications from enteral and parenteral treatments and any sequelae during or as a result of watchful waiting).

  • Time to disimpaction, without the need for endoscopic intervention.

  • Patient satisfaction scores for different treatment strategies.

  • Length of hospital stay.

  • Re‐presentation with soft food bolus impaction within follow‐up period of the study.

Search methods for identification of studies

We conducted systematic searches of the published and unpublished literature to identify randomised controlled trials relevant to our review question. There were no restrictions related to year of publication, publication status, or language of publication, and we would have arranged translations if appropriate. If further data were required to report the primary outcomes, we would have sought clarification from the study authors directly.

Electronic searches

We searched the following electronic databases to identify relevant studies. We last conducted the searches on 18 August 2019.

  • Cochrane Central Register of Controlled Trials (CENTRAL) (searched via Ovid; up to Issue 7, 2019) (Appendix 2).

  • MEDLINE (searched via Ovid; 1946 to 18 August 2019) (Appendix 3).

  • Embase (searched via Ovid; 1974 to 18 August 2019) (Appendix 4).

  • CINAHL (Cumulative Index to Nursing and Allied Health Literature) (searched via EBSCO; 1982 to 18 August 2019).

Searching other resources

We searched the reference lists of the articles retrieved, including those of review articles. We attempted to contact authors of relevant studies to ask them to identify any other published and unpublished studies. We searched for errata or retractions of eligible studies at www.ncbi.nlm.nih.gov/pubmed on 21 August 2019.

Data collection and analysis

Selection of studies

Two review authors (JH and NS) independently screened the titles and abstracts of studies identified by the above search strategy. We identified and excluded duplicates, and then coded unique articles as either 'retrieve' (eligible or potentially eligible/unclear) or 'do not retrieve' if clearly irrelevant. For articles coded as 'retrieve', we obtained the full‐text publication. Two review authors (JH and NS) then independently assessed the text to identify studies for inclusion. We excluded ineligible studies, recording the reasons for exclusion in the Characteristics of excluded studies tables. Any disagreements were resolved through discussion or in consultation with a third review author (JS). Had we identified multiple reports of the same study, we would have collated these, so that each study, rather than each report, formed the unit of interest in the review. The selection process is recorded in a PRISMA flow diagram (Figure 1).


PRISMA flow diagram of study selection process.

PRISMA flow diagram of study selection process.

Data extraction and management

We used a standard data collection form for study characteristics and outcome data that was pre‐piloted and adapted as required. Two review authors (JH and NS) independently extracted study characteristics. We attempted to extract the following study characteristics.

  • Methods: study design, total duration study and run‐in, number of study centres and location, study setting, withdrawals, date of study.

  • Participants: N, mean age, age range, gender, severity of condition, diagnostic criteria, baseline lung function, smoking history, inclusion criteria, exclusion criteria.

  • Interventions: intervention, comparison, concomitant medications, excluded medications.

  • Outcomes: primary and secondary outcomes specified and collected, and time points reported.

  • Notes: funding for study, notable conflicts of interest of study authors.

Two review authors (JH and NS) independently extracted outcome data from the included studies (for details see Characteristics of included studies). No outcome data were reported in an unusable way. Any disagreements would have been resolved by consensus or by involving a third review author (JS); this was not required as there were no disagreements. One review author (JH) entered the data from the data collection form into the Review Manager 5 file (Review Manager 2014). A second review author (NS) verified this for accuracy.

Assessment of risk of bias in included studies

Two review authors (JH and NS) independently assessed risk of bias using the criteria outlined in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011). There were no disagreements between review authors requiring arbitration by a third review author. We assessed bias for the following domains.

  • Random sequence generation.

  • Allocation concealment.

  • Blinding of participants and personnel.

  • Blinding of outcome assessment.

  • Incomplete outcome data.

  • Selective outcome reporting.

  • Other bias.

We graded each potential source of bias as either high, low, or unclear and have provided quotes from the study report, together with a justification for our judgement, in the 'Risk of bias' table. Had information on risk of bias related to unpublished data or correspondence with a trial author, we would have noted this in the 'Risk of bias' table. When considering treatment effects, we assessed the risk of bias for the studies that contributed to that outcome.

Assessment of bias in conducting the systematic review

We conducted the review in accordance with the published protocol, reporting any deviations from it in the Differences between protocol and review section.

Measures of treatment effect

We analysed dichotomous data as risk ratios. We would have reported continuous data as mean difference or standardised mean difference. We would have summarised time‐to‐event outcomes using hazard ratios. We would have undertaken meta‐analysis if this were meaningful, that is if the treatments, participants, and the underlying clinical question were similar enough for pooling to make sense.

We did not encounter any reporting of medians and interquartile ranges, which may have suggested skewed data, but would have reported this and considered its implications.

Had we encountered multiple study arms in a single study, we would have included only the relevant arms. If the same meta‐analysis needed two comparisons, we would have halved the control group to avoid double counting.

Unit of analysis issues

We identified no non‐standard parallel group random allocation study designs. Had we identified cross‐over studies, we would only have considered the results from the first phase of the study, prior to cross‐over.

Dealing with missing data

We attempted to contact study investigators to clarify key study characteristics and to obtain missing outcome data. Where appropriate, we would have followed intention‐to‐treat principles.

Assessment of heterogeneity

We would have used the I² statistic to measure heterogeneity amongst the studies in each analysis (Higgins 2003). In the case of substantial heterogeneity, we would have performed subgroup analysis.

Assessment of reporting biases

Had we identified more than 10 studies for any individual parameter, we would have produced a funnel plot to explore potential publication bias. Sensitivity analysis for missing data was not required.

Data synthesis

For quantitative analysis, we would have performed a meta‐analysis using Review Manager 5, Review Manager 2014, and a random‐effects model (Deeks 2011).

'Summary of findings' table

We created a 'Summary of findings' table for the outcome disimpaction of the soft food bolus prior to endoscopic intervention.

We used the five GRADE considerations (study limitations, consistency of effect, imprecision, indirectness, and publication bias) to assess the certainty of the body of evidence for this outcome. Two review authors performed the GRADE assessment (JH and NS), reaching a score by consensus and not requiring arbitration by a third review author (JS).

We used the methods and recommendations described in Section 8.5 and Chapter 12 of the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011), employing GRADEpro software (GRADEpro 2015). We justified decisions to downgrade or upgrade the certainty of the evidence in footnotes.

Subgroup analysis and investigation of heterogeneity

Had it been applicable, we would have performed subgroup analysis of the type of conservative treatment, grouped by substance type (irrespective of dose, regimen, or route) or watchful waiting, with the aim of determining if any single enteral or parenteral treatment outperformed another, including watchful waiting. We would have used only the primary outcome measures.

Sensitivity analysis

Had it been required, we would have performed a sensitivity analysis including only studies at low risk of bias for all domains outlined in the Assessment of risk of bias in included studies section.

Reaching conclusions

We based conclusions on the findings from this review. We planned to outline implications for both practice and research.

Summary of findings and assessment of the certainty of the evidence

Results

Description of studies

See Characteristics of included studies, Characteristics of excluded studies, and Characteristics of studies awaiting classification for further details.

Results of the search

We identified a total of 987 records through the electronic searches, and one further record through the peer review process. We excluded 98 duplicate records, leaving 890 unique records. We excluded 809 clearly irrelevant records after title and abstract assessment, retrieving the full texts of the remaining 81 records for further assessment. We excluded 79 records and included one randomised controlled trial that met the inclusion criteria. There were no ongoing studies and one study awaiting classification, after the paper was provided by a reviewer but verification of the data was outstanding. The process of study selection is outlined in Figure 1.

Included studies

Tibbling 1995 is a randomised, placebo‐controlled, double‐blinded, parallel‐group trial including 43 participants, co‐ordinated from University Hospital, Linköping, Sweden. Three other Swedish hospitals participated (University Hospital Uppsala and the central hospitals of Jönköping and Norrköping), though the recruitment rates at individual sites are not described. Participants were randomised to receive either intravenous diazepam and glucagon or identically appearing placebos. The primary outcome was disimpaction of the foreign body. It was not stated how the disimpaction was assessed, though radiological confirmation was required for inclusion in the study. The effects of the drugs were followed for one hour before the initial outcomes were recorded. Disimpactions occurring after one hour were also recorded, though no standardised time point for this assessment was declared. There was no indication of any a priori power calculation, but the authors report that their intention was to recruit 40 participants. The study was conducted over a two‐year period and published in 1995 in the journal Dysphagia (Springer‐Verlag New York Inc).

Excluded studies

We identified one other randomised trial evaluating oesophageal impaction (Mehta 2001), which we excluded as it looked only at coin impactions. Reasons for exclusion of the majority of the other studies that passed initial screening were retrospective/prospective observational cohort studies, or limited case reports, and not experimental trials with randomisation. For further details see Characteristics of excluded studies.

Risk of bias in included studies

We assessed the risk of bias in the included study, Tibbling 1995, using Cochrane's 'Risk of bias' tool as described in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011).

Allocation

Tibbling 1995 does not specify the randomisation ratio, but it is assumed to be 1:1. Randomisation was carried out centrally in advance by a pharmacologist who retained the code until recruitment had completed.

Blinding

Both active substances and placebos in Tibbling 1995 were clear, colourless liquids distributed in identical glass ampoules from a central pharmacy. Investigators and participants were thus blinded as to the nature of the substances administered. There is no indication that the concealment was broken at any point during the trial for any participants.

Incomplete outcome data

Results are presented for 43 participants in Tibbling 1995. There is no indication that any participants were recruited and randomised but failed to complete the study. There was slight imbalance in the recruited groups, with 24 receiving active substances and 19 receiving placebos.

Selective reporting

Tibbling 1995 appears to have presented outcomes for all 43 randomised participants. There was no declared intention to perform subgroup analysis, and no subgroup analysis was reported.

Other potential sources of bias

No baseline characteristics were presented for comparison of the active substances and placebo group in the Tibbling 1995 publication. Confirmation that the groups, although randomly allocated, were equivalent, would have been reassuring. Differences in comorbidities, such as oesophageal strictures and hiatus hernias, could have influenced the likelihood of a food bolus clearing spontaneously.

Data on the time until endoscopy was performed for the comparable groups were not provided. A delay could have allowed more time for the bolus to clear spontaneously, thereby influencing the success rates seen between the two groups if significantly different.

Effects of interventions

See: Summary of findings 1 Diazepam and glucagon compared to placebo for the management of impacted food bolus in the oesophagus

See summary of findings Table 1 for the main comparison.

Primary outcome measures

Disimpaction

The only data available were from the Tibbling 1995 publication of 43 participants. The rates of disimpaction for the active substance and placebo groups were 37.5% (n = 9/24) and 31.6% (n = 6/19), respectively (risk ratio 1.19, 95% confidence interval 0.51 to 2.75, P = 0.69). It was not stated how disimpaction was measured, radiologically or clinically. The effects of the drugs were assessed after one hour of the treatments being administered. If the food bolus was still impacted, then the participant was prepared for oesophagoscopy under general anaesthetic. Within this initial hour, four participants disimpacted across both groups. An additional 11 participants were said to have subsequently disimpacted and so did not undergo endoscopy. The trial methodology did not standardise the time at which the endoscopy was intended to be performed. As such, we are not able to comment further on the timeframe for these later disimpactions as no relevant data were presented. We attempted to contact the study authors for clarification on this point but did not received a response.

For the 15 participants who did not undergo oesophagoscopy, the criteria for confirmation of disimpaction was not reported. In 26 of the 28 participants undergoing oesophagoscopy, an impacted foreign body was extracted. It is not reported if the two remaining participants had the bolus identified at the time of the procedure. It is therefore possible that the two participants had a bolus present at the time of the procedure that was then advanced into the stomach, rather than being extracted via the mouth, or if there was in fact no bolus present, implying that it had passed prior to endoscopy, and the procedure could have been considered unnecessary. With only 43 participants randomised in the trial, these two cases could have significantly influenced the success rate if they were both in the same treatment group.

Serious adverse events

No incidence of aspiration, perforation, or death was reported as resulting from either the conservative management or the endoscopic intervention (Tibbling 1995). Of note, it is not reported whether the oesophagoscopy was performed with flexible or rigid instruments.

Secondary outcome measures

Tibbling 1995 reported adverse events in 3 of the 24 participants receiving active substances: 2 experienced a burning sensation at the injection site, and 1 experienced hiccups. It was not reported which agent caused which side effect(s). Only 5 minutes were allocated between the two drugs being administered, and so attributing cause and effect may have been impossible regardless.

Tibbling 1995 did not report the time for the impaction to clear. The only available data were that 3 of the 24 participants receiving active substances and 1 of the 19 participants receiving placebos were reported to have disimpacted within one hour of administration.

Patient satisfaction scores, length of stay, and re‐presentation to hospital were not reported.

Discussion

Summary of main results

Soft food bolus impaction in the oesophagus is a frequently encountered condition in emergency departments around the world. A variety of non‐procedural interventions are used to manage the condition and are reported in the literature. Despite this, there is a paucity of randomised trials on the topic, with only a single study addressing the issue identified in this review (Tibbling 1995). Based on this study, there is uncertainty as to the effects of active substances on the rate of disimpaction of oesophageal soft food boluses, when compared with placebo. There were insufficient data to comment on serious adverse events of any treatment regimen considered in this review.

Overall completeness and applicability of evidence

The single identified trial assessed two intravenous medications commonly used in the management of impacted oesophageal soft food boluses, namely diazepam and glucagon. Both of these drugs were administered to each participant randomised to the active intervention group. As such, we could not assess the efficacy of either substance individually.

We identified no eligible studies addressing other parenteral treatments. Similarly, we identified no eligible studies investigating enteral treatments. Consequently, the completeness of evidence addressing the treatments within the scope of this review is low.

The evidence identified here is applicable to adult patients, without a history of oesophageal stricture, presenting to emergency departments with an impaction history of less than two days. However, the generalisability to an international population is limited due to the contribution from only a single country, and the small sample size means we have low confidence that this is representative of even that population.

Quality of the evidence

The overall certainty of the evidence contributing to the main outcome measure of disimpaction was low. The effect size was not significant, and the 95% confidence interval was wide, reflecting the low precision of the findings in the single contributing study. We identified no evidence for other outcome measures.

We did not identify any incomplete or unreported trials in the review process, and so we feel that the risk of reporting bias and publication bias for this topic is low.

Potential biases in the review process

The protocol was published prior to the start of the formal review process. We feel that the search strategy was robust enough to have identified all potentially contributory evidence. At least two review authors were involved in the screening and identification of relevant studies and the extraction and analysis of data. All four review authors were involved in writing and approving the manuscript through consensus. As such, we feel the opportunity to introduce bias into the review process has been limited.

Agreements and disagreements with other studies or reviews

There are no other systematic reviews and meta‐analyses in the literature that address this topic and consider only randomised controlled trials. There are numerous reviews and articles reporting the findings of observational studies, but none considering only experimental studies that are directly comparable.

It is not possible to comment on concordance of individual studies within the literature as only a single randomised trial was identified.

PRISMA flow diagram of study selection process.

Figuras y tablas -
Figure 1

PRISMA flow diagram of study selection process.

Comparison 1: Diazepam and glucagon compared to placebo for the management of impacted food bolus in the oesophagus, Outcome 1: Disimpaction

Figuras y tablas -
Analysis 1.1

Comparison 1: Diazepam and glucagon compared to placebo for the management of impacted food bolus in the oesophagus, Outcome 1: Disimpaction

Summary of findings 1. Diazepam and glucagon compared to placebo for the management of impacted food bolus in the oesophagus

Diazepam and glucagon compared to placebo for the management of impacted food bolus in the oesophagus

Patient or population: management of impacted food bolus in the oesophagus
Setting: 4 Swedish ear, nose, and throat (ENT) departments
Intervention: diazepam and glucagon
Comparison: placebo

Outcomes

Anticipated absolute effects* (95% CI)

Relative effect
(95% CI)

№ of participants
(studies)

Certainty of the evidence
(GRADE)

Comments

Risk with placebo

Risk with diazepam and glucagon

Disimpaction

Study population

RR 1.19
(0.51 to 2.75)

43
(1 RCT)

⊕⊕⊝⊝
LOW 1

No significant effect from combined diazepam and glucagon compared to placebo

32 per 100

38 per 100
(16 to 87)

*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).

CI: confidence interval; RCT: randomised controlled trial; RR: risk ratio

GRADE Working Group grades of evidence
High certainty: We are very confident that the true effect lies close to that of the estimate of the effect.
Moderate certainty: We are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different.
Low certainty: Our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect.
Very low certainty: We have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect.

1We assessed imprecision as very serious as the single identified study had a wide 95% confidence interval spanning 1.0.

Figuras y tablas -
Summary of findings 1. Diazepam and glucagon compared to placebo for the management of impacted food bolus in the oesophagus
Comparison 1. Diazepam and glucagon compared to placebo for the management of impacted food bolus in the oesophagus

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1.1 Disimpaction Show forest plot

1

43

Risk Ratio (M‐H, Random, 95% CI)

1.19 [0.51, 2.75]

Figuras y tablas -
Comparison 1. Diazepam and glucagon compared to placebo for the management of impacted food bolus in the oesophagus